LC16Recalls & reported problems

Lenstec Barbados Inc · Box of 10 1.6mm LC16 injector cartridges · Class 1

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00844369018944), received between Jul 31, 2025 and Jul 31, 2025 — classified as 1 malfunction.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

No Apparent Adverse Event1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionJul 31, 2025No Apparent Adverse Event; No Apparent Adverse Event
LENSTEC RECEIVED AN EMAIL STATING "LENS WAS NOT COMING OUT OF THE CARTRIDGE CORRECTLY. DOCTOR REMOVED FROM THE EYE AND TOLD THE TECH TO RELOAD. WHEN SHOOTING IT OUT OF THE DEFECTIVE CARTRIDGE IT SNAPPED THE CARTRIDGE AND BECAME STUCK. PER THE DOCTOR USED A NEW LENS." ALSO, STATED "4 BOXES WITH DEFECTIVE LOT #; 1 BOX ALREADY USED DURING CASES AND HAD TO RELOAD DURING CASE. AFTER RELOADING INTO NEW (NON-DEFECTIVE) CARTRIDGE LENS INSERTED FINE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22679644 ↗

Device details

UDI-DI	`00844369018944`
Brand	LC16
Model	LC16
Company	Lenstec Barbados Inc
Product code	MSS · Folders And Injectors, Intraocular Lens (Iol)
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 14, 2024

Device type (GMDN): Intraocular lens-insertion cartridge

A sterile device designed to contain an intraocular lens (IOL), that may have been pre-folded, to facilitate the insertion (launching) of the folded IOL into the anterior or posterior chamber of the eye through a small incision during ophthalmic surgery. Commonly known as the cartridge, it is typically made of synthetic material and is designed as a funnel-shaped tube that terminates at the distal end in a narrowed opening; the IOL is placed into the wider proximal end. The cartridge is attached to an injector for the insertion, and is removed from the injector once the IOL has been successfully inserted. This is a single-use device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.